BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE, SILVERTRACE FOAM RECT CARBON

    MDR report key: 6274330 · Received January 24, 2017

    Report

    Report Number
    3010838917-2017-00020
    Event Type
    Death
    Date Received
    January 24, 2017
    Date of Event
    January 11, 2017
    Report Date
    January 24, 2017
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO COMPLAINT SAMPLE IS AVAILABLE. AFTER COMPLETING X-RAY ON THE PATIENT A SHADOW WAS FOUND. DOCTOR UTILIZED THE GASTRIC CAMERA AND FOUND VISCOUS SECRETION IN THE STOMACH AND THE FOREIGN MATERIAL WAS REMOVED. THIS FOREIGN MATERIAL COULD NOT BE IDENTIFIED. MSDS SHEET WAS PROVIDED TO THE FACILITY. CUSTOMER WAS UNABLE TO CONFIRM IF THE CUSTOMER INGESTED THE GEL AND THEY REPORTED THE DEATH IN A FOLLOW-UP EMAIL. NO FURTHER ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IT WAS POSSIBLE FOR THE PATIENT TO SWALLOW THE ECG. WE DON'T KNOW WHETHER THE INJURY OR MEDICAL INTERVENTION IS REQUIRED OR NOT. THE CUSTOMER REQUESTED US ABOUT THE IMPACT OF HEALTH HAZARD. ADDITIONAL INFORMATION RECEIVED 13JAN2017 - PATIENT INFORMATION: AGE: (B)(6), SEX: FEMALE, PRIMARY DISEASE: RENAL INSUFFICIENCY(DIALYSIS PATIENT) BACKGROUND (B)(6) 2017 START TO OFF-FOOD TREATMENT; (B)(6) 2017 THE PATIENT CAUGHT PNEUMONIA. SHE RECEIVED X-RAY. IN THE STOMACH, THERE WAS A SHADOW OF 10 MM, 7 MM. ON (B)(6) 2017 THE DOCTOR USED THE GASTRIC CAMERA AND FOUND THE FM OF VISCOUS SECRETION IN HER STOMACH. IN ADDITION, THE DOCTOR REMOVED THE FM FROM HER STOMACH. (THE DOCTOR HAS THE FM). ON (B)(6) 2017 THE DOCTOR USED THE GASTRIC CAMERA AGAIN, BUT THERE WAS NOTHING. ADDITIONAL INFORMATION RECEIVED 16JAN2017 - PATIENT HAS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56284 ELECTRODE, SILVERTRACE FOAM RECT CARBON ELECTRODE, ELECTROCARDIOGRAPH DRX LEONHARD LANG GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 90 Death